FDA proposes guidelines for generic abuse-deterrent opioids

The FDA is seeking stricter rules for generic drug makers of opioid-based medicines.FDA

In the latest attempt to curb the spiraling opioid epidemic, generic companies will face new drug development requirements before they can sell copycat versions of abuse-deterrent opioids, according to a draft guidance released today by the Food and Drug Administration.

Notably, the agency is recommending that generic drug makers run a variety of studies and provide data analyses to demonstrate that their medicines are no less abuse-deterrent than the brand-name products on which they base their own medications.

Every day, more than 40 Americans die from overdoses of opioid painkillers, according to the US Centers for Disease Control and Prevention. And each year, 2 million people abuse or misuse the drugs.

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“We recognize that abuse-deterrent technology is still evolving and is only one piece of a much broader strategy to combat the problem of opioid abuse,” said FDA commissioner Robert Califf in a statement. But he maintained that encouraging generic alternatives can achieve that goal, especially since these are generally lower-cost alternatives to brand-name medicines.

The draft guidance, however, won’t be finalized until after a 60-day comment period and the agency digests the reactions. Nonetheless, this marks the second time in as many weeks that the FDA has taken steps to address the opioid epidemic.

Last week, the FDA required immediate-release prescription opioids — which are usually prescribed for treating short-term pain — like Vicodin to have Black Box warnings on their labels about the risk of abuse, addiction, overdose, and death. A Black Box is the most serious type of side effect warning.

These moves are part of a so-called action plan the FDA is undertaking to address the problem. The program also includes expanded use of expert advisory committees; developing warnings and safety information for immediate-release opioid products; and requiring drug makers to better monitor cases of misuse and abuse.

To what extent the draft guidance will accomplish its goal is uncertain. One physician believes the draft guidance may be laudable but, ultimately, may not address the wider problem.

“The greater concern is whether the tamper resistance and abuse deterrence of the original formulation is sufficient. Many people abuse and misuse opioids orally, in which case tamper resistance will be essentially ineffective,” said Dr. Lewis Nelson, an emergency medicine specialist at the New York University Langone Medical Center.

“The Internet is filled with videos and blogs demonstrating ways to bypass the tamper resistant mechanisms to release drug for abuse by other routes … This effort cannot be relied upon as the major approach to reducing opioid abuse,” he said.

Meanwhile, the CDC last week published guidelines that recommend doctors prescribe opioids only after other therapies have failed and to rely on the lowest possible doses.

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Those guidelines, however, have sparked controversy among patient groups, some of which receive financial backing from drug makers. They argue that doctors are likely to become overly cautious about prescribing and some patients will be unfairly prevented from obtaining needed pain relief.

Other efforts are under way to address physician prescribing. Some states, for instance, have introduced bills. And a few local governments have filed lawsuits against several drug makers – including Purdue Pharma, Johnson & Johnson, and Endo Pharmaceuticals – accusing them of downplaying risks and pushing doctors to write prescriptions. The New Hampshire attorney general is investigating the same allegations.